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Weekly Drug News Round-Up: September 20, 2017
Posted yesterday in Pharmaceutical News
FDA Approves Mvasi: The First Cancer Biosimilar A biosimilar is a biological product derived from a living organism deemed highly similar to an already-approved biological product Read More... The first biosimilar to treat cancer has been approved by the the U.S. Food and Drug Administration (FDA) -- Amgen’s Mvasi (bevacizumab-awwb) -- a biosimilar to Genentech’s Avastin (bevacizumab). Mvasi is...
Read moreHealth Highlights: Sept. 21, 2017
Posted today in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: More Fetal Deaths, Fewer Pregnancies When Flint Had High Lead Levels in Drinking Water: Study There was an increase in fetal deaths and a decrease in pregnancies when Flint, Michigan had high levels of lead in its drinking water, a new study says. The analysis of 2008 to 2015 health records from the city and 15...
Read moreWhen Adults Show Determination, Babies Copy
Posted today in Medical
THURSDAY, Sept. 21, 2017 -- Grit and determination are not necessarily ingrained. Rather, they're qualities learned from a very young age, a new lab experiment demonstrates. Children as young as 15 months old learn tenacity from watching their parents, and will try harder after watching an adult struggle to succeed at a task, said lead researcher Julia Leonard. Toddlers in her lab tried twice as hard to make a new...
Read moreFrequent Blood Donations Safe for Some, But Not All
Posted today in Medical
THURSDAY, Sept. 21, 2017 -- Some people may safely donate blood as often as every eight weeks -- but that may not be a healthy choice for all, a new study suggests. The study was done in the United Kingdom, where experts recommend that blood donors wait 12 to 16 weeks before giving again. That's in contrast to the United States, where blood donations are already allowed at eight-week intervals. The study -- a...
Read morePremature Births Cost Health Plans Billions
Posted today in Medical
THURSDAY, Sept. 21, 2017 -- Premature births cost U.S. employer-sponsored health plans billions of dollars a year, a new study claims. About 1 in 10 infants in the country are born prematurely (less than 37 weeks gestation), putting them at increased risk for birth defects and long-term health problems. Employer-sponsored health plans spent at least $6 billion extra on premature infants born in 2013, and a large...
Read moreChlorine plus Pee equals Breathing Trouble for Waterpark Workers
Posted today in Medical
THURSDAY, Sept. 21, 2017 -- Another summer ends, and at least some of America's waterpark attendants may be breathing easier, a new report finds. The research -- conducted at an unnamed indoor waterpark in Ohio last year -- found that high levels of chlorine in water can mix with patrons' sweat and urine to create a toxic atmospheric brew. In fact, the investigation "found that waterpark employees were...
Read moreOptinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
Posted 2 days ago in New Drug Approvals
YARDLEY, Pa.--(BUSINESS WIRE)-- September 18, 2017 -- Optinose, an ENT / Allergy specialty pharmaceutical company, announced today that the U.S. Food & Drug Administration (FDA) approved the Company’s New Drug Application (NDA) for Xhance (previously referred to by the development name OPN-375) for the treatment of nasal polyps in patients 18 years of age and older. It is estimated that up to 10 million A...
Read moreFDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease
Posted 2 days ago in New Drug Applications
CRANBURY, N.J., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the oral precision medicine migalastat for the treatment of patients with Fabry disease with amenable mutations. The FDA's Fast Track program is designed to expedite the development and review of drugs and biologics with the potential...
Read moreFDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD
Posted 2 days ago in New Drug Approvals
London UK – 18 September 2017 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary d...
Read moreFDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
Posted 2 days ago in New Drug Approvals
NEWARK, N.J.--(BUSINESS WIRE) September 18, 2017 --Symbiomix Therapeutics today announced the U.S. Food and Drug Administration (FDA) has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be e...
Read moreCamurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder
Posted 3 days ago in New Drug Applications
Lund, Sweden – 18 September 2017 — Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for weekly and monthly CAM2038 buprenorphine depots for the treatment of adults with opioid use disorder (OUD) and granted a Priority Review. The NDA for CAM2038 was submitted on July 19, 2017 by Camurus’ U.S. partner Braeburn Pharmaceuticals and compr...
Read moreFDA Approves New Indication for Ipsen’s Somatuline Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
Posted 3 days ago in New Drug Approvals
Paris (France) September 18, 2017 -- Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy. Somatuline Depot is also approved for the...
Read moreNeos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD
Posted 6 days ago in New Drug Approvals
DALLAS and FORT WORTH, Texas, Sept. 15, 2017 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release products using its proprietary modified-release drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved Adzenys ER™ (amphetamine) Extended-Release Oral S...
Read moreFDA Advisory Committee Votes Unanimously for Shingrix (HZ/su) in the US for Prevention of Herpes Zoster (Shingles) in Adults Ages 50 and Over
Posted 8 days ago in New Drug Applications
London UK 13 September 2017 -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations...
Read moreAbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Posted 2 weeks ago in New Drug Applications
NORTH CHICAGO, Ill., Sept. 6, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being...
Read moreSanofi Receives Tentative FDA Approval of Admelog (insulin lispro injection) 100 units/mL
Posted 2 weeks ago in New Drug Applications
BRIDGEWATER, N.J., Sept. 1, 2017 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus. The tentative approval is based on physicochemical, non-clinical and ...
Read moreMonthly News Roundup - August 2017
Posted 2 weeks ago in Pharma Industry News
Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy History was made this month as the U.S. Food and Drug Administration (FDA) approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR) T-cell therapy. Kymriah (tisagenlecleucel or CTL019) from Novartis was approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic...
Read moreFDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
Posted 5 weeks ago in Pharma Industry News
August 17, 2017 -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with ...
Read moreFDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
Posted 5 weeks ago in Pharma Industry News
August 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient...
Read moreMonthly News Roundup - July 2017
Posted 7 weeks ago in Pharma Industry News
FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of two types: either genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor regimen, or genotype 1a or 4 previously treated with a sofosbuvir regimen without an NS...
Read moreFDA Clears First Neonatal Magnetic Resonance Imaging Device
Posted 8 weeks ago in Pharma Industry News
July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum Peiris, M.D., M.P.H., chief med...
Read moreNabriva Therapeutics Announces Positive Topline Results from Global, Phase 3 Clinical Trial Evaluating IV and Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia
Posted 3 days ago in Clinical Trials
DUBLIN, Ireland and KING OF PRUSSIA, Pa., Sept. 18, 2017 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1)...
Read moreBiohaven And Alzheimer’s Disease Cooperative Study (ADCS) Announce Phase 2 Clinical Trial Collaboration Evaluating Glutamate Modulating Agent Trigriluzole In Patients With Mild-to-moderate Alzheimer’s Disease
Posted 6 days ago in Clinical Trials
New Haven, Connecticut (NYSE: BHVN) September 15, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, announced today its clinical trial collaboration with the Alzheimer’s Disease Cooperative Study (ADCS). The ADCS is a leading Alzheimer’s disease (AD) clinical trial...
Read moreMirati Therapeutics Presents Positive Preliminary Data From On-Going Clinical Trials Of Sitravatinib In Non-Small Cell Lung Cancer
Posted 7 days ago in Clinical Trials
SAN DIEGO, Sept. 14, 2017 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology biotechnology company, announced that positive preliminary data from two ongoing clinical trials of sitravatinib in non-small cell lung cancer (NSCLC) will be presented Friday, September 15th, 2017 at the IASLC 2017 Chicago Multidisciplinary Symposium in Thoracic Oncology (learn more at...
Read moreTetraphase Pharmaceuticals Completes Enrollment of IGNITE3 Phase 3 Clinical Trial of Eravacycline in Complicated Urinary Tract Infections
Posted 10 days ago in Clinical Trials
WATERTOWN, Mass., Sept. 11, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced completion of enrollment in IGNITE3, its ongoing phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to...
Read moreAbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis
Posted 10 days ago in Clinical Trials
NORTH CHICAGO, Ill., Sept. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were...
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